Method and device for sterile packaging of a ready-to-use flexible hydrophilic intraocular lens

ABSTRACT

The invention relates to a method and a device for packaging a flexible hydrophilic intraocular lens ( 1 ) placed flat on an injection support ( 4 ) which is adapted to carry out folding of the lens ( 1 ) during its implantation. The lens is immersed in a bath of liquid conserving solution contained in a sealed flask ( 30 ) which is itself enclosed in a packaging envelope ( 48 ), the assembly being steam-sterilized.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation Application of U.S. patentapplication Ser. No. 15/670,910 filed Aug. 7, 2017, which is aContinuation of U.S. patent application Ser. No. 10/580,914, filed onMay 30, 2006, now U.S. Pat. No. 9,751,649 B2, issued Sep. 5, 2018, whichwas filed as the National Phase of PCT International Application No.PCT/FR2003/003575, filed on Dec. 3, 2003, which claims the benefit ofpriority to French Application No. 02/15294, filed on Dec. 4, 2002, allof which are hereby expressly incorporated by reference into the presentapplication.

BACKGROUND OF THE INVENTION

The invention relates to a method and a device for packaging andconserving in a sterile condition a flexible hydrophilic intraocularlens which is ready to use, i.e. ready to be implanted by injectionthrough an incision formed in the wall of a patient's eye.

Flexible intraocular lenses have the advantage of being able to befolded, allowing them to pass through incisions of small dimensions. Toachieve this folding and injection of the lens into the eye, variousdevices have been proposed. For example, WO 9628121 and WO 9615743propose, in the case of lenses which can be conserved dry (made ofnon-hydrophilic materials such as silicones), disposable injectiondevices comprising a folding cartridge and an injection device. The lenscan be loaded into the cartridge before packaging and steamsterilization in an autoclave.

WO 9820819 also describes a packaging device for an injection kit for anon-hydrophilic lens, comprising a chamber for storing the lens in thenon-folded state, and a device for transferring and folding the lens inan injector chamber. The assembly is held on a support plate itselfenclosed by an envelope. In this case, too, the assembly can besterilized.

However, such devices are not compatible with intraocular lenses calledhydrophilic lenses, made of hydrophilic material(s) which need to bekept in a hydrated state for conservation.

Throughout the present text the term “hydrophilic lens” refers to anylens formed by a material such that it needs to be maintained in aliquid solution for conservation before use. Such lenses may be made,for example, of materials referred to as “hydrogel”, “acrygel” or“acrylic” (the latter term deviating from its normal meaning), whichmaterials are PMMA (polymethylmethacrylate) and/or HEMA(hydroxymethylmethacrylate), hydrated to more than 16%, in particularbetween 24% and 28%. U.S. Pat. No. 4,787,904 also describes variousexamples of materials that may be used to produce a hydrophilic lens.

Hydrophilic lenses have the particular advantage of goodbiocompatibility. In particular, they are compatible with naturalaqueous humor from the chemical, physical and optical (appropriate angleof contact) points of view. In addition they have high flexibility,allowing them to be folded and/or rolled to facilitate their insertionthrough an incision of reduced dimensions, in particular through theincision formed to introduce into the eye the material necessary for theprior surgical treatment (for example, an incision of 3 mm to 3.5 mm forablation of the lens by phaco-emulsification). In addition they have atthe same time good shape memory, so that they regain their initialfunctional shape after insertion into the eye.

However, the problem arising with these hydrophilic lenses is preciselythat of folding and manipulating them at the moment of the surgical act.U.S. Pat. No. 4,787,904 proposes to conserve the lens in the pre-foldedstate in the injection device while being immersed in a conservingsolution, the whole assembly being contained in a flexible packagingpocket. However, this method cannot be used in practice, for two mainreasons. Firstly, a lens which has remained folded for a long periodbefore use necessarily retains a shape memory of the folded state andtherefore does not regain its perfect initial functional shape afterimplantation.

In addition, such packaging cannot be steam-sterilized (autoclave) afterproduction. The liquid solution in the pocket would cause excesspressure, leading to explosion of the pocket. The production of such apackage is therefore not compatible with the imperative requirements ofsterilizing the lens and its packaging.

As a result, hydrophilic lenses up to now have been conserved flat insterilized rigid flasks of conserving solution. At the moment of thesurgical act, the surgeon removes the lens using a pincer, folds it(optionally with the aid of a folding device) or places it in afolding/injection cartridge or in an injector and injects it into theeye. All these manipulations are relatively complex and delicate,increasing the risk of contamination and damage to the lens.

SUMMARY OF THE INVENTION

It is therefore an object of the invention to mitigate thesedisadvantages by proposing a method and a device for packaging aflexible hydrophilic intraocular lens by which:

-   -   the lens is conserved flat in a liquid conserving solution and        is folded only at the moment of the surgical act;    -   sterility of the packaging and of the lens is easily achieved        and can be guaranteed up to implantation, despite the presence        of the liquid conserving solution;    -   the packaging is sealed and does not present any risk of leakage        of the liquid conserving solution before, during or after        sterilization;    -   the lens does not have to be manipulated at the time of        implantation, either to fold it or to inject it.

Furthermore, it is an object of the invention to propose a method and adevice for packaging which are simple and inexpensive. In particular, itis an object of the invention to propose a single-use packaging devicewhich is disposable after implantation of the lens and is compatiblewith different models of lenses.

To achieve these objects, the invention relates to a method forpackaging a flexible hydrophilic intraocular lens in which:

-   -   the lens is placed on an injection support including an        implantation end through which the lens can be slid and ejected        for intraocular implantation, this injection support being        adapted to receive and carry the lens and to be associated with        an injection device including a thruster piston able to push the        lens on the injection support towards the implantation end;    -   the lens and the injection support are placed in a packaging        containing a volume of liquid lens conserving solution which        bathes the lens and keeps it hydrated, wherein:    -   an injection support is used which is adapted to receive and        carry the lens flat and to carry out folding of the lens before        the latter is ejected via the implantation end;    -   the lens is placed flat on the injection support and is immersed        in a bath of liquid conserving solution contained in a rigid        liquid-tight flask which is closed;    -   the assembly is then steam-sterilized, in particular by being        placed in an autoclave in a steam bath at high temperature        (above 130° C., in particular 132° C., for more than 20 min, in        particular 21 min).

According to the invention, before sterilization the rigid flask(containing the lens and the solution, and closed) is advantageouslyplaced in an outer packaging envelope compatible withsteam-sterilization.

The invention also includes a device for carrying out a method accordingto the invention.

The invention therefore also relates to a device for packaging andconserving in a sterile condition an intraocular lens, comprising:

-   -   an injection support including an implantation end through which        the lens can be slid and ejected for intraocular implantation,        said injection support being adapted to receive and carry the        lens and to be associated with an injection device including a        thruster piston able to push the lens on the injection support        towards the implantation end;    -   a flexible hydrophilic intraocular lens placed on the injection        support;    -   a packaging enclosing at least the lens, the injection support        and a volume of liquid lens conserving solution which bathes the        lens and keeps it hydrated,

wherein:

said injection support is adapted to receive and carry the lens flat andto carry out folding of the lens before the latter is ejected via theimplantation end;

-   -   the lens is carried flat on the injection support and is        immersed in a bath of liquid conserving solution contained in a        closed liquid-tight rigid flask, and    -   the assembly is in the sterilized state.

According to the invention, the rigid flask is advantageously enclosedin an outer packaging envelope compatible with steam sterilization andthe assembly is in the sterilized state.

The sterilized state of the device can be verified and guaranteed in amanner known per se, for example, by means of colored markingsguaranteeing sterilization which are modified if the envelope iscontaminated or risks being contaminated. The packaging device accordingto the invention includes at least the lens, the injection support andthe liquid conserving solution in the rigid flask. It may contain otheraccessory elements.

According to the invention, use is advantageously made of an injectionsupport adapted to carry out folding by a simple translational movementimparted to the lens when the latter is pushed towards the implantationend. Thus, the injection and folding support is without moving parts(only the piston being movable), which simplifies the packaging deviceand makes it more reliable. Folding (this term also including rolling)is achieved by means of guide surfaces, in particular helicoidal ortapering surfaces, formed in the injection support to guide the edgeportions of the lens.

In a first variant of the invention use is made of an injection supportcarried detachably by a closing stopper of the rigid flask. Theinjection support, like the lens carried on it, is maintained immersedin the liquid solution in the flask by means of the stopper. At the timeof use, the stopper is separated from the flask, then the injectionsupport is separated from the stopper, then the injection support isassociated with an injection device having a thruster piston. It shouldbe noted that while this is done the lens is never manipulated, pinchedor folded by tools; all risk of deterioration or contamination istherefore avoided.

In a second preferred embodiment of the invention, use is made of aninjection support associated with an injection device including a hollowcylindrical body for receiving the thruster piston, which is adapted toslide in a sealed manner in the cylindrical body. In addition, the rigidflask and the cylindrical body are adapted to be fixed together rigidlyin a sealed manner, the injection support extending into the liquidconserving solution in the rigid flask, but to be fixed together in sucha way that they can be separated from one another in order to use theinjection device for implantating the lens.

In this way the totality of the device necessary for implanting the lensby injection, including the lens, the injection and folding support andthe injection device with thruster piston, are incorporated in the samepackaging and are steam-sterilized together with the liquid solution andthe rigid flask. At the time of use, it is sufficient to extract theinjection device (carrying the injection support and the lens) from thepackaging, to separate said injection device from the rigid flask and toinject the lens, without any additional handling. The term “hollowcylindrical body” refers to a body the internal wall of which has agenerally cylindrical shape in the mathematical sense of the term, thatis, having a cross-section which is not necessarily circular (althoughthis shape, corresponding to a cylinder of revolution, is preferred),and which may be, for example, elliptical or other. The hollowcylindrical body and the thruster piston have conjugate shapes to ensureliquid-tightness between them, including during translational movementsof the thruster piston in the hollow cylindrical body. They thereforeform a device comparable to a syringe.

According to the invention, the rigid flask and the cylindrical body areadvantageously fixed to one another by screwing one end of the rigidflask onto the outer wall of the cylindrical body. According to theinvention, a seal is advantageously provided to ensure liquid-tightnessbetween the rigid flask and the outer wall of the cylindrical body.

According to the invention, the device advantageously includes meansforming an axial stop preventing premature extraction of the thrusterpiston from the hollow cylindrical body.

In this way extraction of the piston from the cylindrical body of theinjection device during sterilisation or at the end of sterilisation,under the effect of the high pressure prevailing in the flask and in theinjection support as a result of the sterilisation, is entirely avoided.

According to the invention, the hollow cylindrical body isadvantageously adapted to form the axial end stop preventing prematureextraction of the thruster piston from the hollow cylindrical body.

According to the invention, the device advantageously includes a sealadapted to be interposed between the axial end stop of the hollowcylindrical body and a sealing block of the thruster piston in itsretracted end position in the hollow cylindrical body. This sealcompressed between the sealing block and the axial stop ensures completeliquid-tightness, in particular during sterilization. As a variant, theaxial stop may be formed by a rigid wall of the packaging envelopeforming a receptacle for the injection device.

In addition, according to the invention the device is advantageouslyprovided with unlockable means for locking the thruster piston in theretracted end position in the hollow cylindrical body. In this way anypremature actuation of the thruster piston, which would risk damagingthe lens, before utilization of the inventive device, is avoided. Toachieve this, it is advantageously provided in a device according to theinvention that the thruster piston includes an operating stem which isnot rotationally symmetrical, that the hollow cylindrical body has anaxial end provided with a non-rotationally-symmetrical opening having ashape matching that of the operating stem, and that the operating stemis mounted so as to be rotatable about its longitudinal axis between alocked position in which it cannot pass through the opening and anunlocked position in which it can pass through the opening.

In addition, according to the invention the injection supportadvantageously includes an adapter bush forming a receptacle for thelens, said bush being adapted to carry and receive different models oflenses, and said adapter bush also being adapted to be mounted in acylindrical end portion of the injection support. In this way, thedevice according to the invention can be used with different types oflens without modification. Manufacturing costs are thus reduced.

The invention also includes a packaging method and device wherein thereare in combination all or some of the characteristics mentionedhereinbefore or hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objectives, characteristics and advantages of the invention willbe apparent from the following description with reference to theappended drawings representing embodiments of the invention which aregiven solely as non-limiting examples, in which drawings:

FIG. 1 is a schematic perspective view of a packaging device accordingto a first embodiment of the invention;

FIG. 2 is an exploded schematic view in axial section of the device ofFIG. 1, the outer envelope not being shown;

FIGS. 3 and 4 are schematic views in axial section in two differentsection planes of the packaging device according to a second, preferredembodiment of the invention, the outer envelope not being shown;

FIG. 5 is an exploded schematic perspective view showing a packagingdevice according to a third embodiment of the invention similar to thesecond embodiment, but with an injection support including an adapterbush;

FIG. 6 is a schematic axial section showing a detail (end of injectiondevice, injection support with bush and lens, and rigid flask) of thethird embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

A packaging device according to the invention is designed for packagingand conserving in a sterile condition a flexible hydrophilic intraocularlens 1 ready for use. Such a lens 1 comprises an optical portion 2 andtwo haptics 3. The lens 1 is placed on an injection support 4 includingan implantation end 5 of tapered external shape, so as to be able to beintroduced through an incision formed in the wall of a patient's eye.The dimensions and the interior shape of the implantation end areadapted to allow the lens 1 to pass through the implantation end and tobe ejected from the implantation end 5 into the internal cavity of theeye.

In practice, the cross-section of the implantation end 5 may becircular, square or rectangular, or more generally polygonal, inparticular as a function of the shape of the lens 1 in its folded stateat the moment of ejection.

Opposite the implantation end 5 the injection support 4 includes areceptacle 6 for a lens 1 in the non-folded state (flat). The receptacle6 is formed inside a substantially cylindrical end portion 7 of theinjection support 4 and opens axially to form an aperture 8 throughwhich the lens 1 can be inserted into the interior of the receptacle 6.

Between the receptacle 6 and the implantation end 5 the injectionsupport 4 includes a folding cone 9 comprising an internal axial conduit10 which communicates at one end with the receptacle 6 and at the otherwith the implantation end 5 and incorporates guiding/folding surfaces 11adapted to guide the edge portions of the lens 1, in particular itsoptical portion 2, in such a way that the lens 1 is folded (or rolled)when it is displaced axially in translation inside the conduit 10 fromthe receptacle 6 to the implantation end 5. The external shape of thefolding cone 9 is preferably substantially tapered so as to connect theouter wall of the cylindrical end portion 7 continuously to that of theimplantation end 5. It should be noted, however, that as a variant anyother form of truncated cone might be envisaged, in particular atruncated pyramid, or even a cylindrical shape.

The guiding/folding surfaces 11 of the conduit 10 of the folding cone 9are formed by the opposed internal lateral walls of the conduit, whichslope towards one another from the receptacle 6 to the implantation end5.

The cylindrical end portion 7 of the injection support 4 is preferablyprovided with radial through-apertures 12 allowing the receptacle 6 tobe supplied with liquid conserving solution from outside the injectionsupport 4.

The outer wall 13 of the cylindrical end portion 7 of the injectionsupport 4 includes fixing lugs 15 projecting radially to the exterior.The injection device 14 has a hollow cylindrical end 33 provided withapertures 16 adapted to receive the lugs 15 of the injection support soas to form quick-fastening means by non-return elastic engagement of theinjection support 4 on the end of the injection device 14. The lugs 15are in the form of latching elements and are adapted to deformelastically radially inwardly to engage in the apertures 16 when theinjection support 4 is introduced axially into the end 33 of theinjection device 14.

In the two first variants, shown in FIGS. 1 to 4, the injection support4 is formed in a single piece constituting at the same time thereceptacle 6, the guiding/folding surfaces 11 and the implantation end5. However, in these variants it is necessary to design the preciseshape of the receptacle 6 as a function of each model of lens 1 which isto be carried in said receptacle 6. In practice, flexible hydrophiliclenses 1 may have different shapes which vary from one anotheressentially by the shape and dimensions of their haptics. The lenses 1also vary significantly in their dimensions.

To avoid having to produce the injection support 4 to match each modelof lens 1 to be implanted, the third variant, shown in FIGS. 5 in 6,provides that the injection support 4 incorporates an adapter bush 81designed to form the receptacle 6 for a lens 1, 1 a, 1 b, 1 c of anymodel. Thus, said adapter bush 81 is able to carry and receive differentlens models 1, 1 a, 1 b, 1 c. The bush 81 is also adapted to bepress-fitted into the cylindrical end portion 7 of the injection support4.

The adapter bush 81 may be formed by a cylindrical sleeve open at bothaxial ends and having in its interior two lateral clips 82 extendingaxially opposite one another to receive the optical part of a lens 1, 1a, 1 b, 1 c. The clips 82 have shapes adapted to receive and retain theoptical part of the lens 1, 1 a, 1 b, 1 c while subsequently allowingits axial translation for the purpose of injection and while beingcompatible with different shapes of existing haptics. In FIG. 6, lens 1a has thick curved haptics, lens 1 b has fine curved haptics and lens 1c is of the “navette” type having four haptics forming loops. These arenon-limiting examples and other shapes of the lens 1 can be envisaged.

In practice, it will be noted that the adapter bush 81 shown in FIG. 6can receive and carry these different models of lens 1. However, aplurality of models of the bush 81 to receive different types of lens 1might equally be provided, at low manufacturing cost.

The cylindrical bush 81 can be introduced and press-fitted into the endportion 7 of the support 4. The bush 81 advantageously has an externalrib 83 extending parallel to the axis of the bush 81 and adapted toengage in a matching groove 84 in the end portion 7 of the injectionsupport 4, so as to mark and determine the angular position of the bush81 with respect to the injection support 4.

The injection support 4 may be formed in one piece in rigid syntheticmaterial, transparent or otherwise, adapted to withstand steamsterilization and made, for example, of polycarbonate orpolymethacrylate.

In the first variant of the invention illustrated, the injection support4 is carried by a flexible rubber stopper 17 having a cylindrical femaleextension 18 adapted to receive the cylindrical end 7 of the injectionsupport 4 in such a way that the injection support 4 is then carried bythe stopper 17. However, the connection of the stopper 17 to theinjection support 4 is detachable in that the injection support 4 can beremoved from the stopper 17 by simply moving the two parts apart.

The stopper 17 is also adapted to close in a sealed manner a rigid flask19 containing a bath of liquid solution 20 for conserving the flexiblehydrophilic lens 1, the injection support 4 and the lens 1 beingimmersed in the bath of liquid solution 20.

The cylindrical outer wall 21 of the extension 18 of the stopper 17 isadapted to be inserted in the neck 22 (open axial end) of the flask 19and close it in a sealed manner. The cylindrical wall 21 is prolongedoutside the neck 22 by a disc-shaped portion 23 which covers the endedge of the neck 22.

The stopper 17 of flexible rubber is preferably itself covered by arigid closing cap 24 adapted to cover the whole stopper assembly in asealed manner and to be screwed onto the rigid flask 19, the stopper 17being squeezed and held in place between the neck 22 and the cap 24. Therigid cap 24 is provided with an internal screw thread adapted tocooperate with a matching thread of the outer wall of the neck 22 of therigid flask. The rigid flask 19 is preferably made of glass or syntheticmaterial, transparent or otherwise, adapted to withstand steamsterilization and made, in particular, of polycarbonate orpolymethacrylate.

The liquid solution 20 contained in the rigid flask 19 does not entirelyfill the internal volume of the rigid flask 19, even after the injectionsupport 4 has been inserted and the rigid flask 19 has been closed. Asufficient volume of air must be retained inside the rigid flask 19 tobe able to absorb pressure variations induced during subsequent steamsterilization. The sealed closure of the rigid flask 19 formed by thestopper 17 and the cap 24 is liquid-tight but not totally impermeable togases, and in particular to pressurized gases such as water vapor.

The rigid flask 19 containing the injection support 4 with a lens 1 isitself enclosed in the interior of a flexible outer packaging envelopecompatible with steam sterilization. Such flexible outer packagingenvelopes are well known per se, in particular for packaging surgicalinstruments. It is adapted to allow water vapor to pass freely into theinterior of the cavity that it delimits, but subsequently to protect itscontents from any possibility of bacterial contamination, and isliquid-tight.

The assembly of the packaging device thus formed contains an unfoldedflexible hydrophilic lens ready for use inside the injection support 4,and said lens 1 is bathed in the liquid conserving solution 20 in theflask 19. The whole assembly can be steam-sterilized by being placed inan autoclave at a pressure and a temperature and for a duration adaptedto permit sterilization of the envelope 25, the flask 19, the injectionsupport 4 and the lens 1.

Before placing the lens 1 in such a packaging device it is, of course,preferable to ensure that all the different elements of said packagingdevice are themselves sterilized. Likewise, the packaging is preferablyproduced in conditions which are as sterile as possible and according tothe applicable standards

After steam-sterilization, the envelope 25 may be provided in a mannerknown per se with one or more colored marking(s) guaranteeing thesterile state and known per se.

To utilize a lens 1 packaged in this way it is sufficient to open theflexible envelope 25 in order to extract the flask 19, to open the rigidcap 24, to remove the stopper 17, to separate the injection support 4from the stopper 17 and to connect the injection support 4 to aninjection device 14, itself previously sterilized. As can be seen, allthe above actions can be carried out while all the elements are in asterile state without specific handling of the lens 1, itself already inposition in its injection support 4. The injection device 14 and theinjection support 4 can be used immediately to implant the lens 1through an incision formed in the patient's eye.

In the second preferred variant of the invention illustrated, theinjection support 4 has been previously fixed to the injection device 14which serves as the stopper for the rigid flask 30 containing the bathof liquid solution 31 for conserving the lens 1. In other words, therigid flask 30 is used to cover and close in a liquid-tight manner theimplantation end 5 of the injection support 4.

The injection device 14 comprises a hollow cylindrical body 32, one endof which forms the cylindrical axial end 33 provided with apertures 16for receiving the fixing lugs 15 of the injection support 4. The outercylindrical wall 34 of said end 33 has an external thread 35 adapted tocooperate with an internal thread 36 formed in the neck 37 of the flask30. In the example shown, the flask 30 is cylindrical and its neck 37 isformed by the open axial end of said cylindrical flask, that is, it hasthe same diameter as the rest of the flask. The thread 35 and the thread36 are adapted to lock when fully screwed together and tightened,producing a liquid-tight seal between them. Thus, they may have avariable self-locking pitch of the type referred to as a “gas or pipethread”. To ensure liquid-tightness between the outer cylindrical wall34 and the flask 30, a tapered male face 60 is provided at the end ofthe outer wall 34 and a matching tapered female face 61 is provided inthe neck 37 of the flask 30, said faces 60, 61 being adapted to comeinto contact with one another when the parts are fully screwed together.As a variant (not shown), a seal may be provided between the faces 60,61 or at another location in the assembly.

The portion of the injection support 4 extending axially outside theinjection device 14 after fixing extends wholly inside the volume of therigid flask 30. To facilitate screwing and unscrewing of the flask 30,the latter is advantageously provided with projecting external ribs 38.

In this way, the rigid flask 30 can be fixed rigidly and in a sealedmanner to the hollow cylindrical body 32 simply by screwing. However, itis likewise possible subsequently to unscrew the rigid flask 30 from thecylindrical body 32 so as to separate the rigid flask 30 from theinjection support 4 and from the injection device 14 in order to injectthe lens 1.

The hollow cylindrical body 32 incorporates a thruster piston 41comprising an injection rod 44 extending axially inside an axial bore 42of the cylindrical body 32. The thruster piston 41 includes an axialejection end 43 adapted to come into contact with the lens 1 positionedin the receptacle 6 and to push said lens 1 axially through the foldingcone 9, then through the implantation end 5 until the ejection end 43itself emerges from the implantation end 5 in order to correctly implantthe lens 1 in the internal cavity of the eye. However, in the packagedstate the thruster piston 41 is retracted inside the hollow cylindricalbody 32, without its ejection end 43 being in contact with the lens 1.

The ejection end 43 of the thruster piston 41 is formed at the end ofthe injection rod 44 of the thruster piston 41, the length of which isadapted to be able to be inserted completely inside the internal conduitformed in the injection support 4, that is, in the receptacle 6, thefolding cone 9 and the implantation end 5. In other words, if L1 is thelength of the injection rod 44 of the thruster piston and L2 is thelength of the internal conduit of the injection support 4 from theopening 8 of the receptacle 6 to the implantation end 5, it must beensured that: L1>L2+ε,

where ε is a length sufficient to ensure that the second haptic of thelens 1 is ejected when the injection rod 44 is pushed fully into theinjection support 4.

The ejection end 43 of the thruster piston 41 preferably has a concaveor forked configuration to cooperate with the lens 1.

Opposite the ejection end 43, the injection rod 44 of the thrusterpiston 41 is formed integrally with a sealing block 45 adapted to closetransversely and sealingly the axial bore 42 of the hollow cylindricalbody 32. The sealing block 45 may be formed of flexible syntheticmaterial in the manner of a piston of a syringe, having a plurality oflips or toric seals 40, its transverse cross-section matching that ofthe bore 42. The thruster piston 41 is prolonged beyond the sealingblock 45 opposite the injection rod 44 by a rigid operating stem 46which extends axially outside the hollow cylindrical body 32 and can bepushed axially into the bore 42 in order to implant the lens 1. Thelength of the hollow cylindrical body 32 corresponds to that of theoperating stem 46 so as to permit manipulations and translationalmovements of the thruster piston 41 into the cylindrical body 32, inorder to implant the lens as indicated above.

The end 72 of the hollow cylindrical body 32 opposite the narrowed end33 has an operating collar 47 like that of a syringe, projectingradially to facilitate depression of the operating stem 46 of thethruster piston 41.

In the embodiment shown in the Figures, the thruster piston 41 is formedby two distinct parts assembled together axially, namely a first part 67forming the injection rod 44 of the thruster piston 41 and the sealingblock 45, and a second part 68 forming the operating stem 46. Forassembling the two parts 67, 68 to one another the sealing block 45 hasopposite the injection rod 44 a split snap-in plug 69 extending axially,and the end 70 of the operating stem 46 is open and provided with ashoulder 71 for locking onto the snap-in plug 69.

The hollow cylindrical body 32 is also formed by two distinct parts,namely a first, main part forming the hollow cylindrical body 32 and asecond axial end piece 66 closing the hollow cylindrical body at itsaxial end 72 opposite its end 33 which receives the injection support 4.

When the end piece 66 is not in position, the first part 67 of thethruster piston 41 can be introduced into the bore 42 of the hollowcylindrical body 32. Once the part 67 has been introduced, the end piece66 can be placed on the end of the cylindrical body 32 to close it. Inthis case, too, the end piece 66 can be fitted to the end 72 of thehollow cylindrical body by simple elastic engagement and locking, forexample, by means of lugs 73 in the form of latching elements projectingradially outwards from the wall 34 of the hollow cylindrical body 32,and matching openings 74 formed in a skirt 75 of the end piece 66 forreceiving the lugs 73.

The end piece 66 also forms the operating collar 47.

Furthermore, the end piece 66 is adapted to form an axial end stop 62preventing premature extraction of the thruster piston 41, i.e.extraction of the injection rod 44 and the sealing block 45, from thehollow cylindrical body 32. This axial end stop 62 is formed by acollar-shaped surface of the end piece 66 adapted to receive axially anopposed collar-shaped surface 76 of the sealing block 45. An annularseal 63 is advantageously interposed between the axial end stop 62 andthe sealing block 45. This seal 63 may be trapped between the stop 62formed by the end piece 66 and a shoulder 77 of the wall of the hollowcylindrical body 32. Thus, when the sealing block 45 is pushed axiallytowards the end 72 of the hollow cylindrical body under the effect ofthe pressure of the liquid prevailing in the interior of the bore 42 (inparticular during steam-sterilization), the sealing block 45 compressesthe seal 63, ensuring complete sealing and preventing any leakage ofliquid.

The end piece 66 closing the hollow cylindrical body is also providedwith a central axial opening 65 through which the operating stem 46passes when it is depressed in order to inject the lens. This opening 65advantageously has a transverse cross-section which is not rotationallysymmetrical. For example, its cross-section has the overall shape of acircle cut by two diametrically opposed chords formed by opposed flatfaces. The end 70 of the part 68 forming the operating stem 46 hasradial dimensions smaller than the distance between the two opposed flatfaces of the opening 65, so that said end 70 can rotate freely in theopening 65. By contrast, the principal running element of the part 68forming the operating stem 46 has a transverse cross-section which isnot rotationally symmetrical but has a shape and dimensions matchingthose of the opening 65 through which it must slide. In the exampleshown, the operating stem 46 therefore has two diametrically opposedflat faces 78. When the flat faces 78 are axially aligned with theopposed flat faces of the opening 65, the stem 46 can be introducedthrough the opening 65 and the thruster piston 41 can be depressed inorder to inject the lens. Conversely, when the flat faces 78 of theoperating stem 46 are not aligned with the flat faces of the opening 65,through rotation of the operating stem 46 about its longitudinal axisand around the plug 69, the operating stem 46, which is outside thehollow cylindrical body and the end piece 66, cannot be inserted intothe opening 65. In this way means of locking the thruster piston 41 inits retracted end position in the hollow cylindrical body 32 areproduced. However, these locking means can be unlocked simply byrotating the stem 46. The locking means prevent premature actuation ofthe thruster piston 41 before use, in particular when the assembly ispackaged and handled for transportation.

Moreover, the injection rod 44 of the thruster piston 41, of smallerdiameter than the sealing block 45, is advantageously guided inside thebore 42 in the region of the end 33 of the body 32 by a cylindricalguide 79 having a shape and dimensions matching those of the rod 44. Theguide 79 is connected to the wall 34 of the hollow cylindrical body 32by a flange 80 provided with openings allowing liquid to pass throughwhen the piston is displaced. To prevent rotation of the rod 44 and thesealing block 45 around their axis, the transverse cross-section of thestem 44, like that of the guide 79, is advantageously not rotationallysymmetrical, being, for example, square.

The injection device 14 thus formed is comparable to a syringe, thesealing block of which is prolonged by the injection rod 44.

The injection device 14 is formed in one piece from a material adaptedto withstand steam sterilization, for example, from polycarbonate orpolymethacrylate (PMMA).

To package a lens 1, the lens 1 is placed flat in the receptacle 6 of aninjection support 4, the injection support 4 is fixed to the end of thecylindrical body 32 of the injection device 14, and the injectionsupport 4 and the end 33 of the hollow cylindrical body 32 areintroduced into the rigid flask 30 by screwing the latter onto the outerwall of the hollow cylindrical body 32 until a liquid-tight seal isobtained. Prior to this, the rigid flask 30 contains a quantity ofliquid conserving solution so adapted that after the rigid flask 30 hasbeen fitted to the hollow cylindrical body 32 the lens 1 is bathed inthe liquid solution 31. It should also be noted that prior to thefitting of the rigid flask 30 a quantity of liquid solution may beintroduced into the interior of the conduit of the injection support 4and of the bore 42 of the hollow cylindrical body 32. The whole assemblyis then bathed in the liquid conserving solution.

The liquid-tightness of the rigid flask 30 closed by the injectiondevice 14 is obtained, firstly, between the hollow cylindrical body 32and the neck 37 of the flask via the screw threads 36 and 35 and,secondly, between the sealing block 45 of the thruster piston 41 and thehollow cylindrical body 32 by means of the lips or seals 40 and the seal63. Thus, it is the injection device 14 which itself serves as thestopper for the rigid flask 30. It might be considered, inversely, thatit is the rigid flask 30 which serves as the stopper for the injectiondevice 14.

After the rigid flask 30 and the injection device 14 have beenpositioned and assembled with the injection support 4 in the rigid flask30, the whole assembly can be placed in a flexible packaging envelope48, then steam-sterilized at a temperature and a pressure and for aduration adapted to achieve sterilization. At the end of sterilizationthere is no risk of the thruster piston 41 being ejected from thecylindrical body 32 through pressure differentials.

To utilize a packaging device according to this second embodiment of theinvention, it is sufficient to extract the assembly formed by theinjection device 14 and the rigid flask 30 from the envelope 48, tounscrew the flask 30 from the cylindrical body 32 so as to extracttherefrom the injection support 4 carrying the lens 1, and thenimmediately to utilize the injection device carrying the injectionsupport 4 to implant the lens 1. As can be seen, no handling of the lens1 is necessary and the latter is perfectly conserved in a sterile statewithin the liquid solution contained in the rigid flask 30.

The invention may be subject to numerous variants with respect to thepreferred embodiments described hereinbefore and illustrated in theFigures, which variants may also be combined. The specific forms of thedifferent elements and the choice of materials, and the relativedimensions, may be different to those described and illustrated.

The invention provides a device which is ready for use and is completelysterile, while avoiding any handling of the lens, the latter, like theinjection device 14 and the injection support 4, being maintained in acompletely sterile condition.

What is claimed is:
 1. A method of a lens package flexible hydrophilicintraocular, comprising: placing the lens on an injection supportincluding an implantation end through which the lens can be slid andejected for its intraocular implantation, said injection support beingadapted to receive and carry the lens and to be associated with aninjection device comprising a pusher piston adapted to push the lens onthe injection support towards the implantation end, wherein the lens isplaced and the support of injection in a packaging enclosing a volume ofliquid solution for preservation of the lens from bathing the lens andthe now hydrated, wherein there is used an injection support adapted toreceive and carry the lens flat and to be able to perform a folding ofthe lens before the latter is ejected through the implantation end,wherein placing the lens flat on the injection support and immersed in abath of liquid solution for retention in a vial rigid impervious toliquids that is closed, and wherein then all sterilized with steam. 2.The method according to claim 1, wherein before sterilization placingthe rigid flask in a packaging wrapper external compatible with steamsterilization.
 3. The method according to claim 1, wherein an injectionsupport adapted to perform a single time by folding translationalmovement to the lens when the latter is pushed towards the implantationend.
 4. The method according to claim 1, wherein an injection supportcarried removably by a stopper closing the rigid flask.
 5. The methodaccording to claim 1, wherein an injection support associated with aninjection device comprising a cylindrical body receiving the hollowpiston pusher adapted to be sealingly slidable in the cylindrical body,and in that the rigid flask and the cylindrical body are adapted to besecured to each other rigidly tight manner, the injection supportextending in the liquid solution of conservation in the rigid flask, butso as to be separated from each other in order to use the injectiondevice for implantation of the lens.
 6. The method according to claim 5,wherein the rigid flask and the cylindrical body are fixed to oneanother by screwing an end of the rigid bottle on the outer wall of thecylindrical body and so as to ensure liquid-tightness between the rigidflask and the outer wall of the cylindrical body.
 7. A device forpackaging and storage in a sterile condition for a lens flexiblehydrophilic intraocular lens comprising: an injection support includingan implantation end through which the lens can be slid and ejected forits intraocular implantation, said injection support being adapted toreceive and carry the lens and to be associated with an injection deviceincluding a thruster piston adapted to push the lens towards animplantation end of the injection support, a lens flexible hydrophilicintraocular lens placed on the injection support, a packaging enclosingat least the lens, the injection support and a volume of liquid solutionconservation of the lens from bathing the lens and the now hydrated,wherein said injection support is adapted to receive and carry the lensflat and to be able to perform a folding of the lens before the latteris ejected through the end of implantation, —the lens is carried flat onthe injection support and immersed in a bath of liquid solution forretention in a vial rigid liquid-tight and closed, wherein the assemblyis in a sterilized condition.
 8. The device according to claim 7,wherein the rigid flask is enclosed in a packaging casing externalcompatible with steam sterilization.
 9. The device according to claim 7,wherein the injection support is adapted to perform a folding simply bytranslational movement imparted to the lens when the latter is pushedtowards the end site.
 10. The device according to claim 7, wherein theinjection support is carried removably by a stopper closing the rigidflask.
 11. The device according to claim 7, wherein the injectionsupport is associated with an injection device comprising a cylindricalbody receiving the hollow piston pusher adapted to be sealingly slidablein the cylindrical body, and in that the rigid flask and the cylindricalbody are adapted to be secured to each other rigidly, of tight manner,the injection support extending in the liquid solution of conservationin the rigid flask, but so as to be separated from each other for use ofthe device injection for implantation of the lens.
 12. The deviceaccording to claim 11, wherein the rigid flask and the cylindrical bodyare fixed to one another by screwing an end of the rigid bottle on theouter wall of the cylindrical body and so as to ensure liquid-tightnessbetween the rigid flask and the outer wall of the cylindrical body. 13.The device according to claim 11, wherein it comprises means forming anaxial stop preventing accidental extraction of the thruster piston outof the hollow cylindrical body.
 14. The device according to claim 13,wherein the hollow cylindrical body is adapted to form the axial endstop preventing the untimely extraction of the thruster piston out ofthe hollow cylindrical body.
 15. The device according to claim 14,wherein it comprises a seal adapted to be interposed between the axialend stop of the hollow cylindrical body, and a block sealing of thethruster piston in an extreme retracted position in the hollowcylindrical body.
 16. The device according to claim 11, wherein it isprovided with unlockable means for locking the thruster piston in anextreme retracted position in the hollow cylindrical body.
 17. Thedevice according to claim 16, wherein the thruster piston comprises amaneuvering rod non-rotationally symmetrical, in that the hollowcylindrical body has an axial end having a lumen non-rotationallysymmetrical, of conjugate shapes from those of the operating rod, and inthat the stem is mounted so as to be rotated about its longitudinal axisbetween a locked position where it cannot enter the lumen and anunlocked position in which it can pass into the lumen.
 18. The deviceaccording to claim 7, wherein the injection support includes an adaptersleeve forming a receiving space of the lens, this sleeve being adaptedto be able to carry and receive different models of lens, and to bemounted in a cylindrical end portion of the injection support.